SCIENTIFIC AND REGULATORY CONSIDERATIONS IN PRODUCT DEVELOPMENT - Pharmaceutical Amorphous Solid Dispersions - page 412

12.6 CONCLUSIONS

Over the last few years, ASDs have provided a useful tool in improving the solubility,
dissolution, and bioavailability of poorly water-soluble drugs. The properties of ASDs
are strongly dependent on the manufacturing process, processing conditions, and the
properties of the drug substance and the carrier polymer(s). A thorough understanding of
the critical material attributes and processing parameters would ensure consistent quality
and physicochemical stability of these drug products. Approval of these drug products is
on the basis of the criteria outlined in the FD&C Act and involves a comprehensive
regulatory review of the quality, safety, and ef

cacy information by a team of reviewers
that include physicians, statisticians, chemists, pharmacologists, and other scientists.
FDA is also encouraging real-time monitoring and control of critical material attributes
and process parameters through timely in-, on-, or at-line measurements. A number of
FDA and ICH guidance documents have also been issued to provide consistency in the
regulatory process and to establish inspection and enforcement procedures.

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